N/A
N=30
Ultherapy™ Treatment Following Sculptra® Treatment
Skin Laxity
Bottom Line
View on ClinicalTrials.gov: NCT01422538 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. — 40; 30; 33 percentage of participants improved
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ulthera® System (Device); Sculptra® (Drug); Sculptra® treatment followed by Ultherapy™ treatment (Other)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Ulthera, Inc
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs. |
40; 30; 33 | — |
| SECONDARY Overall Aesthetic Improvement at 90 Days Post-treatment |
50; 60; 67; 70; 60; 56 | — |
| SECONDARY Overall Aesthetic Improvement at 180 Days Post-treatment |
30; 33; 43; 70; 44; 43 | — |
| SECONDARY Subject Satisfaction at 90 Days Post-treatment |
70; 60; 78 | — |
| SECONDARY Subject Satisfaction at 180 Days Post-treatment |
70; 63; 38 | — |
Summary
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged 35 to 60 years.
- Subject in good health.
- Skin laxity in the lower face and neck.
- Grade 1 and 2 on the Knize Scale
Exclusion Criteria
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face and neck.
- Excessive skin laxity on the face and neck.
- No scarring in areas to be treated.
- Any open facial wounds or lesions.
- Acne on the face.
- Patients who have a history with keloid formation or hypertropic scarring
- Patients who have a hypersensitivity to injectable poly-L-lactic acid
- Presence of a metal stent or implant in the facial area to be treated.
Data sourced from ClinicalTrials.gov (NCT01422538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.